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Remifentanil vs Fentanyl for analgesia in mechanically ventilated ICU patients
NCT05003570Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2021
- Primary completion
- Dec 2022
- Countries
- 1
- Sponsor
- Southeast University
- Modality
- Orthosteric Ligands
- Drugs
- remifentanil
- Conditions
- pain
01
Overview
Phase 3, randomised, double-blind trial of remifentanil in pain (2 arms), sponsored by Southeast University. Primary endpoint: Analgesia success rate at 72 hours. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Remifentanil Arm
Remifentanil analgesia combined with propofol sedation.
Fentanyl Arm
Fentanyl analgesia combined with propofol sedation.
03
Who it enrols
Adult patients (18-80 years) requiring invasive mechanical ventilation for more than 12 hours, excluding those with opioid or propofol allergies, deep sedation (RASS <= -4), or expected survival less than 48 hours.
04
Endpoints
Primary
Analgesia success rate
Secondary
Proportion of optimal time (CPOT score ≤2)
Number of times the remedial sedative drug propofol was used
Proportion of subjects using the salvage sedative drug propofol
Dosage of the remedial sedative drug propofol
Wearing time from mechanical ventilation
Extubation time
Success rate of wearing mechanical ventilator
Duration of study drug use in ICU
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